TriClip G5 Delivery System - TCDS0801-XT
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- TriClip G4 System FDA PMA
- Generic Name
- Tricuspid valve repair device, percutaneously delivered FDA PMA
Identifiers
- PMA Number
- P230007 FDA PMA
- FDA Product Code
- NPS FDA PMA
- Models / Variants
- TCDS0801-NT FDA PMATCDS0801-NTW FDA PMATCDS0801-XT FDA PMATCDS0801-XTW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The TriClip G5 Delivery System is a percutaneously delivered tricuspid valve repair device. It is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate.
Supplied as a delivery system for the TriClip G4 System, it is used in cardiovascular procedures under FDA PMA authorization (P230007). The system includes models TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, and TCDS0801-XTW, and is manufactured by Abbott Medical in St. Paul, MN.
Frequently asked questions
What is the TriClip G5 Delivery System used for?
The TriClip G5 Delivery System is used to deliver the TriClip G4 System for percutaneous tricuspid valve repair in patients with symptomatic severe tricuspid regurgitation who are at intermediate or greater surgical risk and have been deemed appropriate for transcatheter edge-to-edge repair by a multidisciplinary heart team.
Which manufacturer produces the TriClip G5 Delivery System?
The TriClip G5 Delivery System is manufactured by Abbott Medical, located at 177 County Rd. B E., St. Paul, MN 55117, as indicated in the device data.
What models are included in the TriClip G5 Delivery System?
The TriClip G5 Delivery System includes the following models: TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, and TCDS0801-XTW, as specified in the product name and specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230007 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P230007 23 fields · synced Sep 18, 2026